FDA 510(k)

Merit RadialFlo Arterial Catheter

Número K: K182538 · 2019-01-16

RequerenteMerit Medical Singapore Pte. , Ltd.

Data da decisão2019-01-16

Código do produtoFOZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Merit RadialFlo Arterial Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Singapore Pte. , Ltd.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K182538. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Merit RadialFlo Arterial Catheter?

Merit RadialFlo Arterial Catheter is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Merit Medical Singapore Pte. , Ltd.. The 510(k) number is K182538.

When did Merit RadialFlo Arterial Catheter receive FDA 510(k) clearance?

Merit RadialFlo Arterial Catheter received FDA 510(k) clearance on 2019-01-16, under 510(k) number K182538.

Who is the listed applicant for Merit RadialFlo Arterial Catheter?

The FDA 510(k) record lists Merit Medical Singapore Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merit RadialFlo Arterial Catheter?

The FDA product code for Merit RadialFlo Arterial Catheter is FOZ.

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